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Health ProfessionalsPatients

No longer recruiting (closed or complete)Last updated: 2 April 2026

This study is recruiting people with HER2+ solid cancers to evaluate how safe, tolerable and effective a new drug (called YH32367) isA Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

Please note, Austin Health are currently only recruiting people with Biliary Tract Cancers.

YH32367 is a new targeted drug. It is a bispecific antibody (BsAb) that targets both HER2 and h4-1BB. It activates 4-1BB signaling, blocks HER2 signaling in HER2+ tumour cells, stimulates IFN-y release from T-cells, and induces tumour cell destruction.

This study has 2 parts: a Dose Escalation part to identify the maximum tolerated dose (MTD) and/or two dose levels for Recommended Phase 2 Dose (RP2D) selection, and a Dose Expansion part, to determine RP2D and to confirm how safe, tolerable and effective YH32367 is at that dose.

The Dose Escalation part will have 8 cohorts. Participants will be assigned to receive YH32367 at the starting dose and the dose being escalated/de-escalated in adjacent dose cohorts.

The Dose Expansion Part has 2 cohorts:

  • Cohort 1: People who were treated with at least 1 prior chemotherapy (gemcitabine and/or cisplatin based) HER2+ biliary tract cancer.
  • Cohort 2: People who have been treated with all available standard treatments and have no available options HER2+ solid cancers other than breast, stomach, gastro-oesophageal junction and biliar tract cancer.

Conditions

This trial is treating people with HER2+ solid cancers

Eligibility

Inclusion

[Dose Escalation Part]

  • Pathologically confirmed HER2-positive
  • Mandatory provision of tumor tissue sample

[Dose Expansion Part]

  • Patients who have at least one measurable lesion

  • Mandatory provision of tumor tissue sample

    1. Cohort 1: Pathologically confirmed HER2-positive biliary tract cancer
    2. Cohort 2: Pathologically confirmed HER2-positive metastatic solid tumor malignancy other than breast and gastric or gastroesophageal junction adenocarcinoma and biliary tract cancer

Exclusion

  • Uncontrolled central nervous system (CNS) metastases
  • Spinal cord compression
  • Carcinomatous meningitis
  • Acute coronary syndromes
  • Heart failure
  • Interstitial lung disease (ILD)
  • Pneumonitis
  • History of a second primary cancer
  • Human immunodeficiency virus (HIV)
  • Active chronic hepatitis B
  • Hepatitis C
  • Systemic steroid therapy
  • Autoimmune disease

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Yuhan Corporation

Scientific Title

A Phase 1/2, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors

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